Clearance Summary
WOUND SPAN BRIDGE III received FDA 510(k) clearance under submission number K781837, sponsored by Howmedica Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1978-11-15.
- Submission: K781837
- Applicant / Sponsor: Howmedica Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1978-11-15
Classification & Regulation
This clearance is catalogued under FDA product code KAS and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.